Principal Regulatory Writer

Principal Regulatory Writer

Reading Full-Time 43200 - 72000 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Lead complex regulatory submissions and guide team members in medical writing.
  • Company: Join Complete Regulatory, part of IPG Health, a top-tier Med Comms agency.
  • Benefits: Enjoy flexible time off, retail discounts, private healthcare, and wellness programmes.
  • Why this job: Be part of a supportive team making a real impact in the pharmaceutical industry.
  • Qualifications: Previous experience as a regulatory writer in pharma or medical writing agency required.
  • Other info: Diversity is celebrated; adjustments for applicants are encouraged.

The predicted salary is between 43200 - 72000 £ per year.

Complete Regulatory is part of IPG Health Medical Communications, providing class-leading writing support and consultancy services to the pharmaceutical industry. We produce a wide range of high-quality clinical documentation, including clinical study reports, protocols, clinical summaries, clinical overviews, regulatory responses, and other supporting documents across various therapy areas.

We are looking for experienced Principal Regulatory Writers with previous experience as a regulatory writer within the pharmaceutical industry and/or a medical writing agency. You will use your thorough knowledge of regulatory documents and development of submission documentation to lead complex submissions and guide other team members.

In this role, you will work as a trusted partner with various companies, providing high-level leadership and support on a range of project types and therapy areas. You will help maintain excellent client relationships, consult with clients, and demonstrate high-level strategic thinking to ensure effective medical writing for regulatory authorities.

This position offers the opportunity to build on your experience in regulatory writing while working within a highly specialised, supportive, and reputable team. You will be rewarded with:

  • Flexible Time Off – uncapped paid time off
  • Retail and gym discounts
  • Great training and development
  • Life assurance
  • Pension
  • Employee assistance programme
  • Private healthcare
  • Mental health wellness programme
  • Cycle to work scheme
  • Long Service Award
  • Season Ticket Loan
  • Flexible working

We celebrate diversity and encourage applicants from all backgrounds and/or disabilities. We want you to have every opportunity to shine and show us your talents, so please reach out and let us know if there are any reasonable adjustments we can make to ensure our assessment process works for you.

Principal Regulatory Writer employer: Complete Regulatory | An IPG Health Company

At Complete Regulatory, part of IPG Health Medical Communications, we pride ourselves on being an exceptional employer that fosters a supportive and innovative work culture. Our commitment to employee growth is evident through our extensive training programmes and flexible working options, allowing you to thrive in your role as a Principal Regulatory Writer while enjoying benefits like uncapped paid time off and private healthcare. Join us in a dynamic environment where your expertise will be valued, and together we can make a meaningful impact in the pharmaceutical industry.
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Contact Detail:

Complete Regulatory | An IPG Health Company Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Principal Regulatory Writer

✨Tip Number 1

Familiarise yourself with the latest regulatory guidelines and standards in the pharmaceutical industry. This knowledge will not only help you during interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.

✨Tip Number 2

Network with professionals in the medical writing and regulatory fields. Attend industry conferences or webinars, and connect with current employees at Complete Regulatory on platforms like LinkedIn to gain insights into their work culture and expectations.

✨Tip Number 3

Prepare to discuss specific examples from your past experience where you successfully led complex submissions or improved client relationships. Highlighting these achievements can set you apart as a candidate who can add immediate value to the team.

✨Tip Number 4

Showcase your leadership skills by discussing how you've guided junior writers or collaborated with cross-functional teams in previous roles. This will align well with the responsibilities of a Principal Regulatory Writer and demonstrate your readiness for the position.

We think you need these skills to ace Principal Regulatory Writer

Regulatory Writing Expertise
Clinical Documentation Knowledge
Strong Understanding of Regulatory Guidelines
Project Management Skills
Attention to Detail
Excellent Communication Skills
Strategic Thinking
Ability to Lead and Mentor Team Members
Experience with Clinical Study Reports
Knowledge of Submission Processes
Collaboration Skills
Problem-Solving Skills
Adaptability to Different Therapy Areas
Client Relationship Management

Some tips for your application 🫡

Understand the Role: Before applying, make sure you fully understand the responsibilities of a Principal Regulatory Writer. Familiarise yourself with the types of documents you'll be working on and the skills required for the role.

Tailor Your CV: Customise your CV to highlight relevant experience in regulatory writing within the pharmaceutical industry. Emphasise your knowledge of regulatory documents and any leadership roles you've held in past projects.

Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for medical communications and your strategic thinking abilities. Mention specific examples from your past experience that demonstrate your capability to lead complex submissions.

Proofread Your Application: Ensure that your application is free from errors. A well-written application reflects your attention to detail, which is crucial for a regulatory writer. Consider asking a colleague to review it before submission.

How to prepare for a job interview at Complete Regulatory | An IPG Health Company

✨Showcase Your Regulatory Knowledge

Make sure to highlight your understanding of regulatory documents and submission processes during the interview. Be prepared to discuss specific examples from your past experience that demonstrate your expertise in producing clinical documentation.

✨Demonstrate Leadership Skills

As a Principal Regulatory Writer, you'll be expected to lead complex submissions and guide team members. Share instances where you've successfully led projects or mentored colleagues, showcasing your ability to take charge and support others.

✨Emphasise Client Relationship Management

Since maintaining excellent client relationships is crucial, prepare to discuss how you've built and nurtured client partnerships in previous roles. Highlight your strategic thinking and how it has positively impacted client outcomes.

✨Prepare for Scenario-Based Questions

Expect scenario-based questions that assess your problem-solving skills and decision-making abilities. Think about potential challenges you might face in the role and how you would approach them, demonstrating your critical thinking and adaptability.

Principal Regulatory Writer
Complete Regulatory | An IPG Health Company
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